Trial Outcomes & Findings for A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. (NCT NCT05834348)

NCT ID: NCT05834348

Last Updated: 2025-03-30

Results Overview

The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator.

Recruitment status

COMPLETED

Target enrollment

5279 participants

Primary outcome timeframe

From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Results posted on

2025-03-30

Participant Flow

Data of eligible participants with non-small cell lung cancer (NSCLC) with age greater than (\>) 18 years at the time of initiating anticancer therapy was collected retrospectively from the 3 national registries: Cancer Registry of Norway (CRN), the Norwegian Drug Registry (NDR) and the Norwegian Patient Registry (NPR) between 1-Jan-2015, and 31-Dec-2022 (maximum up to 96 months). The study was conducted in Norway.

Available data was evaluated as per the study objectives, from 23-Jun-2023 to 23-Jan-2024 (approximately 7 months) in this retrospective observational study.

Participant milestones

Participant milestones
Measure
Biomarker Cohort
Participants with NSCLC who were positive for biomarkers (epidermal growth factor \[EGFR\] or anaplastic lymphoma kinase \[ALK\] or ROS proto-oncogene 1 \[ROS1\]) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Overall Study
STARTED
618
4661
Overall Study
COMPLETED
618
4661
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Total
n=5279 Participants
Total of all reporting groups
Age, Continuous
67.1 Years
STANDARD_DEVIATION 13 • n=618 Participants
70.7 Years
STANDARD_DEVIATION 9.7 • n=4661 Participants
70.2 Years
STANDARD_DEVIATION 10.2 • n=5279 Participants
Sex: Female, Male
Female
385 Participants
n=618 Participants
2158 Participants
n=4661 Participants
2543 Participants
n=5279 Participants
Sex: Female, Male
Male
233 Participants
n=618 Participants
2503 Participants
n=4661 Participants
2736 Participants
n=5279 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows.

The duration of treatment of anti-cancer drugs was calculated as median time to treatment (mToT) for first line treatment and the median total ToT for all treatment lines (mTToT) for the anticancer therapies for EGFR+, ALK+ and ROS1+ and was presented in this outcome measure. mToT measured the time on the treatment participants receive as first line treatment, measuring the time from they start the treatment until they stop the first line treatment (or end of follow up), using the Kaplan Meier estimator. mTToT measured the time on all treatment - from the time they start first line treatment, until the point they stop their last treatment line (or end of follow up), using the Kaplan Meier estimator.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=398 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=49 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving osimertinib: mToT
11 Months
Interval 10.1 to
The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib: mTToT
8.1 Months
Interval 5.6 to 18.8
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving brigatinib: mToT
11 Months
Interval 4.7 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving brigatinib: mTToT
16 Months
Interval 11.1 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving crizotinib: mToT
7 Months
Interval 2.9 to 21.6
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving crizotinib: mTToT
19 Months
Interval 10.5 to 37.0
Duration of Treatment of Anti-cancer Drugs
ROS1+ participants receiving crizotinib: mToT
5 Months
Interval 2.4 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
ROS1+ participants receiving crizotinib: mTToT
18 Months
Interval 4.9 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib: mToT
3 Months
Interval 2.6 to 13.3
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib: mToT
0.9 Months
Interval 0.9 to 6.5
Duration of Treatment of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib: mTToT
6.3 Months
Interval 3.7 to 26.7
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving osimertinib: mTToT
14 Months
Interval 11.1 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving other TKI: mToT
9.4 Months
Interval 8.2 to 11.2
Duration of Treatment of Anti-cancer Drugs
EGFR+ participants receiving other TKI: mTToT
15.8 Months
Interval 13.7 to 18.1
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving alectinib: mToT
20 Months
Interval 14.7 to 23.7
Duration of Treatment of Anti-cancer Drugs
ALK+ participants receiving alectinib: mTToT
28 Months
Interval 18.0 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.

PRIMARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure; "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.

Number of participants were classified and reported according to the Anti-cancer drugs received during first-line, second-line and third-line treatment after diagnosis of NSCLC.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=2656 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in first line
104 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving IO and/or ChT in second line
53 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in second line
25 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving afatinib in second line
22 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in third line
11 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alecitinib in first line
55 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in first line
29 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alecitinib in second line
14 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving lorlatinib in second line
12 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving gefitinib in first line
86 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in first line
50 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving crizotinib in first line
2 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in first line
93 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in second line
19 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving other drugs in second line
20 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving IO and/or ChT in third line
17 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving osimertinib in third line
13 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
EGFR+ participants receiving erlotinib in third line
3 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving brigatinib in first line
21 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in first line
10 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in second line
4 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in second line
21 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving lorlatinib in third line
6 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving alectinib in third line
4 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving crizotinib in third line
2 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ALK+ participants receiving other drugs in third line
8 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving IO/ChT in first line
13 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving crizotinib in first line
5 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving other drugs in first line
4 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving crizotinib in second line
2 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
ROS1+ participants receiving other drugs in second line
4 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib in first line
23 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in first line
26 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving IO/ChT in first line
2540 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving crizotinib in second line
7 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in second line
13 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving IO/ChT in second line
22 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving other drugs in second line
16 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving erlotinib in third line
1 Participants
Number of Participants Classified According to Treatments of Anti-cancer Drugs
Non-biomarker participants receiving other drugs in third line
8 Participants

PRIMARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number Analyzed" signifies number evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.

Number of participants were classified and reported according to the treatment lines received including first-line, second-line and third-line treatment after diagnosis of NSCLC.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: third line treatment
20 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ROS1+: first line treatment
22 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: first line treatment
335 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: second line treatment
139 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
EGFR+: third line treatment
44 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: first line treatment
115 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ALK+: second line treatment
51 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
ROS1+: second line treatment
6 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: first line treatment
2589 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: second line treatment
58 Participants
Number of Participants Classified According to Treatment Lines of Anti-cancer Drugs
Non-biomarker: third line treatment
9 Participants

PRIMARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to date of death (until 31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number Analyzed" signifies number evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.

OS was defined as time from treatment initiation of anticancer therapy to date of death due to any cause. Analysis was performed by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Overall Survival (OS)
All participants: 2015-2019
19 Months
Interval 16.5 to 21.2
5 Months
Interval 4.9 to 5.8
Overall Survival (OS)
All participants: 2020-2022
23 Months
Interval 19.5 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
7 Months
Interval 5.8 to 7.0
Overall Survival (OS)
EGFR+ participants: 2015-2019
18 Months
Interval 15.3 to 19.3
Overall Survival (OS)
EGFR+ participants: 2020-2022
23 Months
Interval 15.6 to
The upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Overall Survival (OS)
ALK+ participants: 2015-2019
24 Months
Interval 17.4 to 54.7
Overall Survival (OS)
ALK+ participants: 2020-2022
NA Months
Interval 23.3 to
The Median and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Overall Survival (OS)
ROS+ participants: 2015-2019
NA Months
The Median, lower and upper limit of 95% CI was not estimable due to insufficient number of participants with events.
Overall Survival (OS)
ROS+ participants: 2020-2022
NA Months
The Median, lower and upper limit of 95% CI was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

The percentage of participants classified according to the disease stages as 3B, 3C, 4A and 4B at the time of diagnosis were reported in this outcome measure. Cancer stages were classified based on tumor size (T), metastasis to nearby lymph nodes (LN) \[N\] and distant metastasis (M). Stages were 3B, 3C, 4A and 4B. Stage 3B (T1N3M0, T2N3M0, T3N3M0 and T4N2M0). Stage 3C (T3N3M0, T4N3M0), Stage 4A (anyT, anyM and M1a/M1b), Stage 4B (anyT, anyM and M1c). where T1=\<3 cm; T2= 3 to \<5 cm; T3= 5 to \<7 cm; T4= \>7cm. N0=not spread to LN; N1=spread to 1 to 3; N2=spread to 4 to 9; N3=spread \>10 axillary LN. M0= no metastasis; M1a= cancer has spread to other lung; M1b= cancer has as a single tumor outside of the chest, such as to a distant lymph node or an organ such as the liver, bones, or brain; M1c= cancer has spread as more than one tumor outside the chest, such as to distant lymph nodes and/or to other organs such as the liver, bones, or brain.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 3C
1.6 Percentage of participants
3.1 Percentage of participants
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 4B
58.6 Percentage of participants
55.1 Percentage of participants
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 3B
3.5 Percentage of participants
5.6 Percentage of participants
Percentage of Participants Classified According to the Disease Stage at the Time of Diagnosis
Stage 4A
36.2 Percentage of participants
36.2 Percentage of participants

SECONDARY outcome

Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

Percentage of participants classified according to the NSCLC histopathological subtype viz adenocarcinoma, non-small cell carcinoma, large cell neuroendocrine carcinoma were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Adenocarcinoma
94.7 Percentage of participants
80.8 Percentage of participants
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Non-small cell carcinoma
5.0 Percentage of participants
16.8 Percentage of participants
Percentage of Participants Classified According to the NSCLC Histopathological Subtype
Large cell neuroendocrine carcinoma
0.3 Percentage of participants
2.4 Percentage of participants

SECONDARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

Number of participants classified according to the selected administered non-cancer drugs (anticoagulants and statins) were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dalteparin
99 Participants
659 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Edoxaban
15 Participants
55 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Fondaparinux
0 Participants
2 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Pravastatin
10 Participants
34 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Warfarin
1 Participants
33 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Heparin
6 Participants
42 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Enoxaparin
79 Participants
523 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Clopidogrel
12 Participants
139 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Acetylsalicylic acid
91 Participants
843 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dipyridamole
5 Participants
41 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Prasugrel
1 Participants
8 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Ticagrelor
2 Participants
14 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Combinations, acetylsalicylic acid
0 Participants
48 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Dabigatran etexilate
2 Participants
28 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Rivaroxaban
14 Participants
103 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Anticoagulant: Apixaban
107 Participants
498 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Simvastatin
47 Participants
375 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Fluvastatin
1 Participants
7 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Atorvastatin
97 Participants
646 Participants
Number of Participants Classified According to the Selected Participant Administered Non-Cancer Drugs
Statin: Rosuvastatin
11 Participants
59 Participants

SECONDARY outcome

Timeframe: From treatment initiation (1-Jan-2015) to end of follow-up (31-Dec-2022) [maximum up to 96 months]; retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Number of Participants Analyzed" contributed data to the table but may not have evaluable data for every row.

Number of packs dispensed to participants at the time of dispensing were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=162 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at first dispensation
131 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at second dispensation
102 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at third dispensation
9 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at fourth dispensation
4 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at first dispensation
71 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at second dispensation
64 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at third dispensation
51 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 1 pack at fourth dispensation
49 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at first dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at second dispensation
3 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at third dispensation
9 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 2 packs at fourth dispensation
8 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at first dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at second dispensation
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at third dispensation
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 3 packs at fourth dispensation
3 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at first dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at second dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at third dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Alectinib: 4 packs or more at fourth dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at third dispensation
86 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 1 pack at fourth dispensation
74 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at first dispensation
6 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at second dispensation
17 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at third dispensation
18 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 2 packs at fourth dispensation
21 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at first dispensation
5 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 3 packs at second dispensation
6 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at first dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at second dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at third dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Osimertinib: 4 packs or more at fourth dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at first dispensation
14 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at second dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at third dispensation
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: <1 pack at fourth dispensation
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at first dispensation
65 Participants
23 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at second dispensation
61 Participants
15 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at third dispensation
57 Participants
7 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 1 pack at fourth dispensation
44 Participants
5 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at first dispensation
4 Participants
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at second dispensation
3 Participants
3 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at third dispensation
4 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 2 packs at fourth dispensation
9 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at first dispensation
3 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at second dispensation
5 Participants
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at third dispensation
5 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 3 packs at fourth dispensation
2 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at first dispensation
0 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at second dispensation
0 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at third dispensation
0 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Erlotinib: 4 packs or more at fourth dispensation
0 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at first dispensation
41 Participants
28 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at second dispensation
31 Participants
24 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at third dispensation
21 Participants
15 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 1 pack at fourth dispensation
19 Participants
10 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at first dispensation
2 Participants
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at second dispensation
4 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at third dispensation
6 Participants
2 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 2 packs at fourth dispensation
4 Participants
1 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at first dispensation
8 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at second dispensation
7 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at third dispensation
4 Participants
0 Participants
Number of Packs Dispensed at the Time of Dispensing
Crizotinib: 3 packs at fourth dispensation
7 Participants
0 Participants

SECONDARY outcome

Timeframe: At time of diagnosis (up to 3 months prior to treatment initiation); retrospective data was retrieved and analyzed during 7 months of this observational study

Population: Analysis population included all eligible participants whose data was retrieved and observed in this retrospective observational study.

Number of participants classified according to the Norwegian health regions were reported in this outcome measure.

Outcome measures

Outcome measures
Measure
Biomarker Cohort
n=618 Participants
Participants with NSCLC who were positive for biomarkers (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Non-biomarker Cohort
n=4661 Participants
Participants with NSCLC with unknown biomarker status (EGFR or ALK or ROS1) and were identified from CRN, NDR or NPR between 01-Jan-2015 to 31-Dec-2022 were included in this retrospective observational study.
Number of Participants Classified as Per Specific Norwegian Health Regions
Central Norway Regional Health Authority
70 Participants
665 Participants
Number of Participants Classified as Per Specific Norwegian Health Regions
Northern Norway Regional Health Authority
44 Participants
488 Participants
Number of Participants Classified as Per Specific Norwegian Health Regions
South-East Norway Regional Health Authority
341 Participants
2427 Participants
Number of Participants Classified as Per Specific Norwegian Health Regions
Western Norway Regional Health Authority
156 Participants
1055 Participants
Number of Participants Classified as Per Specific Norwegian Health Regions
Unknown
7 Participants
26 Participants

Adverse Events

Biomarker Cohort

Serious events: 0 serious events
Other events: 0 other events
Deaths: 364 deaths

Non-biomarker Cohort

Serious events: 0 serious events
Other events: 0 other events
Deaths: 3780 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Results disclosure agreements

  • Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
  • Publication restrictions are in place

Restriction type: OTHER